780 nm SPY Portable Handheld Imaging (SPY-PHI) System
FDA 510(k) K261037 · Stryker Endoscopy
510(k) numberK261037
Submission
- Device name
- 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- March 30, 2026
- Decision date
- May 28, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was 780 nm SPY Portable Handheld Imaging (SPY-PHI) System cleared by the FDA?
780 nm SPY Portable Handheld Imaging (SPY-PHI) System (K261037) received a 510(k) decision of Substantially Equivalent on May 28, 2026, 59 days after the submission was received.
What is the product code of K261037?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.